The use of a sterilization tray, container or cassette for sterilization and storage of medical and/or dental instruments or implants is well known. The sterilization device usually consists of a tray, or base, and a cover. Both the tray and cover have vertical or near vertical walls on all sides which allow for the tray and cover to mate forming an enclosed container. It is common for the tray and cover to be perforated to allow sterilization and high temperature gasses and fluids to enter and exit the container. The tray and cover may be sheet metal or rigid thermoplastic.
The containers or enclosures are of various height, width and depth depending on the type and size of instruments to be sterilized, autoclaved, or lyophilized. The tray and cover may be separate components or removeably hinged to each other and may contain one or more latching devices to secure the cover to the tray. In some designs the latches form handles for movement of the enclosure as a single unit. Most of the units are stackable, whether for autoclaving or for storage.
The instruments are generally held within the sterilization tray in spaced relation to each other and within the walls of the tray. The means of holding the instruments with the tray includes a variety of instrument supports, clamping members, elastomeric forms, elastomeric mats and other instrument retaining means. Instrument support may be horizontal in a longitudinal direction, compartmentalized or vertically stacked. Tray and cover designs include selectively located holes or slots used as locating tabs for small barriers or walls for customizing component trays within the tray or cover. In previous designs the finger mat, instrument support bracket, clamp, compartments and customizable compartment sides are separate components that require assembly, securing and risk of component loss.
Various other approaches may employ an upright flexible silicone bracket with trunnion and pivoting lid requiring a minimum of a four part assembly or a cylinder containing internal and external threads that must be unthreaded to expose the instruments for use. All of these sterilization tray configurations require the practitioner to use a time-consuming step of removing a separate lid, unclipping or disengaging, minimally, a two-piece assembly. The latching apparatus is also prone to damage with repeated use. With medical and dental practitioners seeing up to 30 patients in one day, many sterilization cycles of the autoclave are required.
Notwithstanding advances made in the prior art, the manufacture of two part instrument sterilization trays from sheet metal remains costly, particularly in higher volumes. Two part sheet metal sterilization tray and lid designs have remained relatively cumbersome and require a hinge or clip element and a latching mechanism that fails frequently with repeated autoclaving.
An advantage of the present invention is provision of an elastomeric lid which acts as both a flexible instrument retention device and a stackable lid for the sterilization tray as a single element. This elastomeric lid, rigid tray design provides a manufacturing cost advantage by providing fewer parts required for assembly. A desired method of manufacture is to directly injection mold the elastomeric lid with an integrated instrument retention member and instrument retention brackets onto the rigid metal or plastic base, thereby further reducing manufacturing costs. The elastomeric lid may also incorporate lid side instrument retention brackets.